Home NDC 67457-926-50 Amphotericin B liposome
Product NDC 67457-926
Requested package NDC 67457-926-50
11-digit product format 674570926
Labeler code 67457
Product ID 67457-926_90f6ce1a-b366-4568-b35c-5a6bbd058bdf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amphotericin B liposome
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA212967
Marketing category ANDA
Marketing start 2025-08-06
Substance AMPHOTERICIN B
Active strength 50 mg/12.5mL
Pharmacologic classes Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212967-001 AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212967-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212967-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL / INJECTION AB 2025-06-30 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amphotericin B liposome
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHOTERICIN B 50 mg/12.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-926-50 Amphotericin B liposome 12.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 12.5 1 67457-926-50 Amphotericin B liposome 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 67457-926-99 Amphotericin B liposome 10 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 10 1 67457-926-99 Amphotericin B liposome 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67457-926-50 67457092650 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE 2025-08-06 No No Current